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510(k) Data Aggregation
(61 days)
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
The LivsMed Inc. ArtiSential Laparoscopic Instruments-Electrodes, Bipolar series (four versions) underwent a series of performance tests to demonstrate its safety and effectiveness.
Here's an overview of the acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance
| Test Clause and Specification | Test Requirement | Reported Device Performance and Remarks |
|---|---|---|
| 1. Appearance | There should be no defects in the appearance of the product and there should be no problem in use. | No crack, stain, or no substances on the surface of the product. |
| 2. Dimension | It shall be within ± 5% of the indicated value of the dimensional term. | Pass. Refer to [Test result] on pages 9-50 at attachment 12. |
| 3. Operational test | The jaw must be smoothly opened and closed and free from jamming, the jaw and hub can be bent up, down, left, and right a range of above ± 80° and are capable of 360° rotation. | The jaw and hub are bent up, down, left and right within above 80° and can rotate 360°. |
| 4. Tensile strength | The jaw and shaft connections shall not be damaged from pulling of 20 N. | No damage to the connection when applying a force of 20N. |
| 5. Feedthrough test | Electricity should be transmitted between the electrode tip and the connector. | The resistance value between the electrode tip and the connector is less than 1Ω. |
| Biocompatibility (Evaluated according to ISO 10993-1 for Cytotoxicity, Intracutaneous Reactivity, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity) | The device should demonstrate biological safety for its intended use. | The device has been evaluated for its biological safety, and all specified endpoints (Cytotoxicity, Intracutaneous reactivity, Skin Sensitization, Acute systemic toxicity, Pyrogenicity) were assessed. The document doesn't explicitly state "passed" for biocompatibility but implies successful evaluation as a prerequisite for submission. |
| Electrical Safety (Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2) | The device should meet the safety requirements for electrosurgical devices. | The device had passed all performed tests. |
| Sterilization (EO-sterilization in accordance with ISO-11135) | The device should be provided sterile and maintain sterility during its shelf life. | The device is provided sterile via EO-sterilization in accordance with ISO-11135. |
| Shelf Life | The device should maintain its performance and sterility for the proposed expiration date. | The proposed expiration date is 3 years from the manufacturing date. Real-time testing will be performed to confirm. |
| Thermal Effect (Histological analysis to porcine tissues: liver, kidney, abdominal muscle) | The electrosurgical device should demonstrate appropriate thermal effects on tissue, without causing excessive or unintended damage, consistent with its intended use for coagulation and dissection. | A histological analysis was performed on thermal effect to porcine tissues (liver, kidney and abdominal muscle) through an electrosurgical device. The document states that the results "demonstrate that the performance requirements were met, the device performs as intended and that the subject device has substantially equivalent performance characteristics to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test within the performance data section (e.g., how many devices were tested for dimensions, tensile strength, etc.). However, the tests are laboratory-based and involve physical and electrical characterization of the device.
- Provenance: This is a premarket notification (510(k)) for a medical device. The tests described are laboratory studies conducted by the manufacturer, LivsMed Inc., based in the Republic of Korea. Therefore, the data provenance is likely from laboratory testing conducted in South Korea. The studies are prospective in the sense that they are conducted specifically to demonstrate the device's conformance to standards and claims for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a physical medical device (laparoscopic instruments-electrodes) and the performance data primarily relates to physical, mechanical, and electrical characteristics, there is no mention of experts establishing a "ground truth" for a test set in the traditional sense of diagnostic accuracy studies. The "ground truth" for these tests is defined by the established engineering specifications, international standards (e.g., IEC, ISO), and performance requirements for electrosurgical instruments.
For the thermal effect study, histological analysis was performed. This would implicitly involve qualified personnel (e.g., pathologists or histotechnicians) to interpret the tissue samples, but the document does not specify their number or qualifications.
4. Adjudication Method for the Test Set
Not applicable. The tests are directly measuring physical and electrical properties against predefined numerical or qualitative criteria. This is not a scenario that typically requires an adjudication method as seen in diagnostic image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret cases. The device in question is a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a manual surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these performance tests is based on:
- Engineering specifications and design requirements: For appearance, dimension, operational tests (jaw movement, rotation), and tensile strength.
- International standards: For biocompatibility (ISO 10993-1), electrical safety (IEC 60601 series), and sterilization (ISO-11135).
- Physical laws/principles: For feedthrough (electrical resistance).
- Histological analysis: For thermal effects, where the "ground truth" would be the observed tissue changes interpreted by qualified personnel against expected outcomes for electrosurgical devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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